Etoposide, Methylprednisolone, High-dose Cytarabine and Oxaliplatin as 2nd Line Therapy for Non-Hodgkin's Lymphoma (NHL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00336583
Recruitment Status : Completed
First Posted : June 14, 2006
Results First Posted : June 22, 2010
Last Update Posted : June 22, 2010
Boryung Pharmaceutical Co., Ltd
Information provided by:
Asan Medical Center

Brief Summary:
Oxaliplatin will be used instead of cisplatin in well-known salvage regimen of etoposide, methylprednisolone, cytarabine and cisplatin (ESHAP). Clinical efficacy and toxicity of this ESHAOX salvage regimen will be evaluated in refractory or relapsed non-Hodgkin's lymphoma patients.

Condition or disease Intervention/treatment Phase
Non-Hodgkin's Lymphoma Drug: Oxaliplatin Phase 2

Detailed Description:
Patients with aggressive non-Hodgkin's lymphoma (NHL) are known to have a malignancy considered curable in many cases. However, diagnosis of refractory or relapsed disease is devastating and the treatment is difficult because regimens of chemotherapy used as salvage therapy are available only in limited numbers. ESHAP, consisting of etoposide, methylprednisolone, high-dose cytarabine and cisplatin, is one of commonly used salvage regimen, and showed its efficacy and feasibility. But it often requires discontinuation of the treatment due to its myelosuppression, neuropathy and renal toxicity, which can also impede further treatment. Oxaliplatin, a platinum coordination complex with an oxalato-ligand as the leaving group and a 1,2-diaminocyclohexane carrier, possesses higher cytotoxic potency on molar basis than cisplatin and carboplatin, and was reported to be active in patients with NHL as a single agent. In addition, the substitution of cisplatin by oxaliplatin in the DHAP regimen, another commonly used one in relapsed or refractory NHL, showed meaningful anti-tumor activity with favorable toxicity profile. Based on preclinical and clinical findings, we will conduct a multi-center phase II study of ESHAOX, which substitutes oxaliplatin with cisplatin in the ESHAP regimen, to evaluate the efficacy and toxicity profile in patients with recurrent or refractory NHL.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 27 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Etoposide, Methylprednisolone, High-dose Cytarabine and Oxaliplatin (ESHAOX) for Patients With Refractory or Relapsed Non-Hodgkin's Lymphoma
Study Start Date : June 2006
Actual Primary Completion Date : December 2006
Actual Study Completion Date : January 2008

Arm Intervention/treatment
Experimental: Oxaliplatin, response
relapsed or refractory non-Hodgkin's lymphoma
Drug: Oxaliplatin
Oxaliplatin, 130 mg per square meter, on day 1
Other Names:
  • etoposide, 40 mg per square meter on days 1 to 4,
  • methylprednisolone, 500 mg on days 1 to 5,
  • cytarabine, 2 g per square meter on day 5

Primary Outcome Measures :
  1. Overall Response Rate [ Time Frame: up to 24 weeks ]
    The Overall Response Rate is measured by the number of patients per the total treatment population who partially or completely responded to treatment. Response will be evaluated according to the International Workshop to Standardize Response Criteria for Non-Hodgkin's Lymphomas.

Secondary Outcome Measures :
  1. Worst Toxicity Grade by Patient [ Time Frame: up to 24 weeks ]
    graded by National Cancer Institute Common Toxicity Criteria of Adeverse Event version 3.0

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 75 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Previously histologically confirmed aggressive lymphomas, defined according to WHO classification (except Burkitt's lymphoma, lymphoblastic lymphoma)
  • Failure to achieve a complete remission with the initial induction chemotherapy, or recurrent disease
  • Performance status (ECOG) ≤3
  • Age ≤ 75
  • Treated with at least one CHOP or CHOP-derived doxorubicin containing regimen
  • At least one or more uni-dimensionally measurable lesion(s) defined as; ≥2 cm by conventional CT or ≥ 1 cm by spiral CT or skin lesion (photographs should be taken) or measurable lesion by physical examination
  • Adequate organ functions defined as; ANC > 1,500/ul, platelet > 75,000/ul, transaminases < 3 X upper normal values; bilirubin < 2 mg%
  • Written informed consent approved by Institutional Review Board

Exclusion Criteria:

  • Any other malignancies within the past 5 years except skin basal cell ca or CIS of cervix
  • Serious co-morbid diseases
  • Pregnancy or breast-feeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00336583

Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of, 138-736
Sponsors and Collaborators
Asan Medical Center
Boryung Pharmaceutical Co., Ltd
Principal Investigator: Cheolwon Suh, MD, PhD Asan Medical Center

Publications of Results:
Responsible Party: Suh, Cheolwon, AsanMedical Center, University of Ulsan College of Medicine Identifier: NCT00336583     History of Changes
Other Study ID Numbers: AMC 2006-130
First Posted: June 14, 2006    Key Record Dates
Results First Posted: June 22, 2010
Last Update Posted: June 22, 2010
Last Verified: September 2009

Keywords provided by Asan Medical Center:
non-hodgkin's lymphoma

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Etoposide phosphate
Methylprednisolone Hemisuccinate
Prednisolone acetate
Methylprednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents